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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS016
Date Received07/16/2003
Decision Date08/12/2003
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1) replace the currently approved catheter kit (ap-07002) with the ip-36633 and ip-3757 kits, 2) replace ip-36633 and ip-3757 connector with codman 3000 (ap-07002) connector, and include titanium as an alternative connector material, 3) add additional components to the kit as a convenience to the physicians and 4) labeling change to the flextip plus intraspinal catheter kit instructions for use to reflect the correct catheter volume.
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